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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Kinked (1339); Volume Accuracy Problem (1675); Intermittent Infusion (2341); Aspiration Issue (2883)
Patient Problems Erythema (1840); Incontinence (1928); Itching Sensation (1943); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Seroma (2069); Therapeutic Effects, Unexpected (2099); Tingling (2171); Twitching (2172); Cramp(s) (2193); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Joint Swelling (2356); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)
Event Date 12/15/2017
Event Type  Injury  
Manufacturer Narrative
Other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from an unknown source via a device manufacturer representative regarding a patient who was receiving clonidine and baclofen at unknown concentrations and dosages via an implantable infusion pump for intractable spasticity and a spinal cord injury/spinal cord disease.It was reported that, since the implant, they could not get the patient's spasticity under control, and the patient had not gotten back to baseline.A motor stall and recovery were seen at the initial interrogation, and were reported to have occurred on 2018-feb-01.The patient did not recently have an mri.It was unknown where the patient was when the motor stall occurred or if there might have been any exposure to a magnetic source.They tried to aspirate the catheter, but could not.A single bolus was programmed, and they got a response.No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a device manufacturer representative, indicating that the cause of the motor stall was not determined.The cause of the inability to aspirate the catheter was not determined.The inability to aspirate the catheter was not resolved.No further complications were reported.
 
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 8780 lot# serial# (b)(4) implanted: 2013 (b)(6) explanted: product type catheter patient code (b)(4) was used for the following verbatim: "decline in function; function had still not improved/declined function; worse physical functioning".If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.The patient had a medical history of hip pain and arthralgia of the hip.On 2017-dec-20 the patient reported that she continued to have more weakness.On 2017 (b)(6), it was reported that the staples were removed and the surgical wound was well healed.The patient was doing better since the pump was replaced.The pump was refilled and the patient was monitored for 30 minutes.On 2018 (b)(6), the patient presented to the hospital with prior cervical spine injury and chronic pain from muscle spasms, who had benefited greatly from having a baclofen pump.Per the progress notes indicated the patient reported being in constant state of pain all over.She had her own bilateral boots and a foley catheter in place.On 2018 (b)(6) the patient was hospitalized with a chief complaint of refractory diffuse muscle spasms and to determine the issue with the new baclofen pump.The admission note stated that all seemed to be well until yesterday, (b)(6) 2017, when she experienced diffuse muscle spasms and urinary incontinence which she described as identical to the symptoms which happened when her pump failed.On an unspecified date, she was initially treated conservatively with oral anti-spasm medications at an outside er (emergency room) and discharged home but returned when it was ineffective.Currently her spasms were under control.In regards to her functional urinary incontinence, she was usually continent of urine but had not had control since the pump failure.A foley catheter was placed at the outside er to minimize skin breakdown risk.She denied fever, chills, sweats, chest or abdominal pain, dyspnea, diarrhea, headache.The patient was treated with scheduled oral baclofen and as needed diazepam.The patient had minimal erythema without pain, or drainage from the surgical site or fever subsequently, the antibiotics were held.Examination showed pump site was healing well with minimal pinkish non-tender erythema.On 2018 (b)(6), the pain physician hospital consult note indicated the patient was seen due to increased spasticity and possible intrathecal baclofen withdrawal.There was a seroma around her pump but no erythema.There was a seroma around her pump but no erythema.There was no evidence of catheter fracture or kink.On 2018 (b)(6), an abdominal x-ray and kub (kidney, ureter, and bladder) study revealed no evidence of disconnection of or kink within the tubing connected to the patient¿s pump.On 2018 (b)(6), a cbc (complete blood count), a bmp (metabolic function test), a urinalysis were taken which had unremarkable results.On 2018 (b)(6), the pump was interrogated and according to the logs the pump was functioning correctly.The pump reservoir was then checked to make sure the pump was accurate.Pump volume was listed to be 37 ml on interrogation and the pump volume obtained was 36 ml indication that the pump was functioning.The physician thought there could be a catheter dislodgment at the pump, and the pump was injected with baclofen subcutaneously which would be the reason for intrathecal baclofen withdrawals.An x-ray of the abdomen was obtained but did not get the catheter aspect of the pump.The catheter was seen anchored closed to the spine but could not see the connection to the pump.The physician's impression was that there was a catheter dislodgment of the intrathecal baclofen pump with baclofen withdrawal and c5 central cord syndrome.The patient was treated with iv benadryl (diphenhydramine) 50 mg every 4 to 6 hours prn spasticity and if not controlled then treatment consisted of iv benadryl, iv ativan (lorazepam) 1 mg every 4-6 hours prn, baclofen 20 mg every 4 hours po (orally).The readout of the pump indicated she was receiving intrathecal baclofen at 1215.2 g/day and clonidine 121.52 g/day.On 2018 (b)(6), the pain physician had reviewed the films and it was difficult to visualize the catheter coming into the pump due to the angles taken.Subsequently, the baclofen pump tubing position/connection to the pump via ap (anterioposterior) of the abdomen were evaluated with an external oblique view to get a bird¿s eye view of the pump.The abdominal x-ray reported to show intact pump/tubing connection.On 2018 (b)(6), the discharge summary/diagnosis by a physician assistant indicated the patient was stable on an oral regimen of baclofen, benadryl and as needed valium.She was discharged to have a catheter dye study since it could not be done in-house.On 05 (b)(6), the patient was hospitalized for observation.She returned to an er (emergency room) due to worsening muscle pain/spasms and transferred to the hospital.Baclofen pump was increased to 20% with noted relief.On (b)(6) 2018, the pump logs showed patient treatment included baclofen 2000 g/ml at 1383.4 g/day and clonidine 200.0 g/ml at 138.34 g/day.On 2018 (b)(6), the pump was interrogated with no perceivable malfunction.It was suspected her symptoms of uncontrolled spasticity were due to autonomic dysreflexia from the cold.On (b)(6) 2018, she was discharged home.On (b)(6) 2018 to baclofen 2000 g/ml at 1506.5 g/day and clonidine 200.0 g/ml at 150.65 g/day in flex mode.On 2018 (b)(6), the patient clinic visit notes indicated the patient had a little pain and spasticity.The pain was aching, dull, exhausting, gnawing, heavy, pulling, sharp, shooting, stabbing and tight and was continuous.The pain radiated pain to leg, foot, knee, hip, ankle, buttock, neck, shoulder, and, fingers and arms.It increased with moving body parts.It was relieved by rest, ice, tylenol (acetaminophen) and activity modification.Pain level with medication was a 10.The pain was relieved by taking medications 60%.After starting medications, she felt better.Current functional level was 2.She was sleeping poorly with 4 hours of sleep per night and waking up 7 times during the night.The patient complained of joint pain, joint stiffness, muscle pain, muscle cramps, and muscle twitches, back pain, and neck pain.The pain level was a 4 out of a scale of 1 to 10.The catheter access port was localized under fluoroscopy with ap and lateral views.The physician attempted to aspirate but was only able to obtain 0.1 ml out of the access port.The physician felt that the catheter could either not be connected all the way or kinked.Her spasticity in the arms was 0 and the physician was able to stretch her pip (proximal interphalangeal joint) and dip (distal interphalangeal joint) without resistance.Subsequently, the pump was delivering medication and although they were unable to aspirate from the catheter, the catheter was patent and medication was flowing in.The pump was refilled and reprogrammed.The patient was monitored for 30 minutes and tolerated the procedure well and there were no complications.On 2018 (b)(6), the patient clinic visit notes indicated the patient was still with pain and spasticity which was improved with ativan.She woke up with numbness in all extremities.The location of the pain was head, neck, back, shoulder, arm, elbow, wrist, had, rib, abdominal, thoracic, hip, leg, knee, ankle and foot, right and left.The pain was aching, dull, exhausting, gnawing, heavy, pulling, sharp, shooting, stabbing and tight and continuous.It was radiating pain to leg, foot, knee, hip, ankle, buttock, neck, shoulder, hand, fingers and arms.It increased with moving body parts.It was relieved by rest, ice, tylenol and activity modification.The pain level with medication was a 10.Pain was relieved by taking medications 60%.After starting medications she felt better.Her current functional level was a 2.The patient¿s sleep was poor and she was sleeping 4 hours per night, waking up during the night 7 times.The patient reported good general health.She reported joint pain, joint stiffness, joint swelling, cold extremities, and difficulty in walking.Pain level was a 4 on a scale of 1 to 10.The physician was not sure if the spasticity was due to the pump adjusted too low or too high.The daily rate was reduced and she was given a bolus at night (at 1600 and 2000) since she had most of her pain at night and see if this helps with spasms.The mri was unchanged.No signs of infection.The pump was interrogated and was working.On (b)(6) 2018, the pump logs showed patient treatment included baclofen 2000 g/ml at 1191.3 g/day and clonidine 200.0 g/ml at 119.13 g/day.On (b)(6) 2018, a mri lumbar spine without contrast medium was normal with no visible mass.On 2018 (b)(6) , the patient clinic visit notes indicated all over body pain with itching over the body and spasms.Her spasticity seemed to be good that day.Her vital statistics were within the normal range.There was less spasticity in her hands on 2018 (b)(6).On 2018 (b)(6) , the patient clinic visit notes indicated the patient is still with episodes of spasticity and pruritus.On a scale of 1 to 10 the pain level was a 4.Vital statistics were within normal range.Overall, the physician did not see much change in her spasticity; she was not at ashworth 4.Her hands were tighter than yesterday, and the rash had improved.Her urine was negative and cbc was normal and she did have an elevated sed (sedimentation rate) but crp (c-reactive protein) was normal so most likely there was no infection.An mri of the lumbar spine and cervical spine do not reveal infection.The physician attempted to drain csf (cerebrospinal fluid) from the catheter access port and was unable to and thus a dye study was not performed.Based on this, the physician decided to change her to a flex program every 4 hours with 200 g over (illegible) of hours for a total of 1200 g/day to see if there was a clog in the tubing.If this did not improve, they might have to send her for an indium scan of the pump.Her therapy was changed to baclofen 2000 g/ml at 1203.6 g/day and clonidine 200.0 g/ml at 120.36 g/day in flex mode.On 2018 (b)(6), the patient clinic visit notes indicated the patient still with decline in function and tightness.Her cervical spine pain, shoulder pain, knee pain and hip pain continued.The patient was unable to transfer without minimum to moderate assist.Her pain was dull, exhausting, heavy and tight and occurred intermittently.It radiated pain and it increased with moving body parts.The pain was relieved by rest, ice and tylenol.Her pain level with medication was a 7.Pain was relieved by taking medications 40%.After starting medications, she felt better.Her current functional level was a 6.She was sleeping 7 hours per night and waking up during the night twice.Her mood was fair.She was having incontinence, muscle pain, cramps, twitches, numbness or tingling sensation, back pain, and neck pain.Her pain level was a 4 out of a scale of 1 to 10.The physician was not sure if there had been any improvement.X-rays were taken of the pump and were sent for analysis since they could not aspirate any fluid from the catheter access port.They may have to open the abdominal wound to access the pump manually.On 2018 (b)(6), the patient clinic visit notes indicated that the patient¿s pain was located in her back, arm and leg, both right and left.The pain was burning, numb, tight and throbbing and was continuous and radiating pain to leg, knee, hip, shoulder, hand and arms.The pain increased with any activity.It was relieved by activity modification.Pain level with medication was at 10.The pain was relieved by taking medications 10%.Her current functional level was a 4 and her physical functioning was worse still with decline in function and tightness.She had a numbness or tingling sensation.She was unable to transfer without minimum to moderate assist.The patient had limb pain on walking.She was sleeping poorly and her mood was fair.She denied having side effects from the current medication and stated "i'm happy with the treatment." they would see if increasing the dose helps.They would reduce the clonidine concentration by 50% and see if it stabilizes.The pump was interrogated and reprogrammed.On 2018 (b)(6), the patient clinic visit indicated the patient had a chief complaint of all over body pain and the patient function had still not improved/declined function and not ambulatory anymore.The location of the pain was head, neck back, shoulder, arm, elbow, wrist, abdominal, hip, leg and knee.The pain site was reported as a right and left.The pain was dull, numb, shooting, stabbing and tight and occurred continuous.She had radiating pain to the leg, hip, buttock, neck, shoulder and fingers and it increased with moving body parts.It was relieved by rest, ice and tylenol.Her pain level with medication was ¿9¿.The pain was relieved by taking medications 40%.After starting the medications she felt better in activities.Her current functional level was "4.¿" she was waking up a number of times during the night.The patient reported incontinence, muscle pain, muscle cramps and twitches, and paralysis.Her hands were tighter than the prior day.There was no further motor stall after the last visit.The plan was to reduce the clonidine by 50% and see if she improved.The patient was referred to the neurosurgeon for pump and catheter replacement due to motor stall in the new pump.Follow up with the patient after (b)(6) 2018.On 2018 (b)(6) , additional information from a physician indicated that on an unspecified date, the patient¿s catheter access failed to obtain drug after replacement.The patient had x-rays and surgery (not further specified).On 2018 (b)(6), the patient's treatment included baclofen 2000 g/ml at 1203.6 g/day.No further complications were reported.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7237850
MDR Text Key98899037
Report Number3004209178-2018-01970
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2018
Date Device Manufactured11/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age53 YR
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